Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses

The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism
• Intervention / Treatment: Device: Lehfilcon A multifocal for astigmatism contact lenses; Device: Samfilcon A multifocal for astigmatism contact lenses; Device: CLEAR CARE® Cleaning & Disinfecting Solution

Detailed Description

Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 days.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94607
      • Dr.Elsa Pao, O.D
    • San Francisco, California, United States, 94127
      • Pacific Rims Optometry
  • Florida
    • Maitland, Florida, United States, 32751
      • Drs. Giedd, P.A.
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care LLC
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Wesley Optometric Consulting
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • Oculus Research, Inc.
  • Ohio
    • Granville, Ohio, United States, 43023
      • Procare Vision Centers, Inc.
    • Powell, Ohio, United States, 43065
      • Insight Research Clinic LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC
  • Texas
    • San Antonio, Texas, United States, 78213
      • Dawn M. Rakich, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
• Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
• Willing to not use readers while wearing study contact lenses for duration of the study;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Monovision contact lens wearers and wearers of contact lens in one eye only;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LID230451, then ULTRA MFfA; Lehfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by samfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.	Device: Lehfilcon A multifocal for astigmatism contact lenses; Investigational multifocal contact lenses for astigmatism; Device: Samfilcon A multifocal for astigmatism contact lenses; Commercially available multifocal contact lenses for astigmatism; Other Names: ULTRA® Multifocal for Astigmatism; Device: CLEAR CARE® Cleaning & Disinfecting Solution; Hydrogen peroxide-based contact lens cleaning and disinfection system; Other Names: CLEAR CARE
Other: ULTRA MFfA, then LID230451; Samfilcon A multifocal for astigmatism contact lenses worn in Period 1, followed by lehfilcon A multifocal for astigmatism contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during typical contact lens wearing hours for at least 8 hours per day during each wear period [30 days (-2/+1)]. Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE.	Device: Lehfilcon A multifocal for astigmatism contact lenses; Investigational multifocal contact lenses for astigmatism; Device: Samfilcon A multifocal for astigmatism contact lenses; Commercially available multifocal contact lenses for astigmatism; Other Names: ULTRA® Multifocal for Astigmatism; Device: CLEAR CARE® Cleaning & Disinfecting Solution; Hydrogen peroxide-based contact lens cleaning and disinfection system; Other Names: CLEAR CARE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses	Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).	Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hyperopia; Toric; Myopia; Multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism; Hyperopia; Presbyopia
• Other Study ID Numbers: CLR624-C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No